TMJ Solutions Inc is recalling 63 units of their TMJ Bilateral Implants (REF: CHG020) because these patient-fitted medical devices contain a discrepancy in the screw hole positions. This defect means the implants may not align correctly with a patient's jaw as intended. The manufacturer has initiated this voluntary recall and is notifying affected customers by letter.
The incorrect screw hole position can prevent the implant from being properly secured to the patient's bone, which may lead to improper fit, surgical delays, or the need for additional corrective procedures.
Sterile EO, Rx Only
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.